510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K122365Substantially Equivalent

Ultracheck Curve Blood Pressure Cuffs

Statcorp Medical, Jacksonville FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K122365 is the FDA 510(k) clearance record for ULTRACHECK CURVE BLOOD PRESSURE CUFFS, a class II device, cleared for Statcorp Medical on under FDA product code OED (Antimicrobial Blood Pressure Cuff). FDA's definition for product code OED reads: "Device is a replacement cuff to be used in conjunction with a non-invasive blood pressure monitor. Together the devices determine blood pressures and heart rate. This particular cuff contains an embedded antimicrobial. A blood pressure...". FDA records list 2 510(k) clearances for Statcorp Medical, from to . As of , FDA records show no recalls naming K122365.

Clearance record

Decision date
Received
(302 days to decision)
Product code
OED Antimicrobial Blood Pressure Cuff
Regulation
21 CFR 870.1120
Device class
Class II
Review panel
Cardiovascular
Applicant
Statcorp Medical 14476 Duval Pl. W., Jacksonville FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OED

Trailing 12 months

FDA records hold no clearances under product code OED in the trailing twelve months.

FDA records show no clearances under product code OED in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OED, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260